NCT05663125

LITT Combined With Early Use of Temozolomide for Recurrent Glioblastomas

Safety and Efficacy of LITT Combined With Early Use of Temozolomide for Recurrent Glioblastomas

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study aims to investigate the safety and efficacy of Laser Interstitial Thermal Therapy (LITT) combined with postoperative early use of temozolomide in treating recurrent glioblastomas.

Detailed description

This is an open-label, non-randomized Phase II study, planning to recruit about ten patients. The primary objective of this study is to investigate the safety of MRI-guided LITT in combination with the early application of temozolomide. The secondary outcome is to explore the efficacy of MRI-guided LITT combined with the early use of temozolomide in treating recurrent glioblastomas.

Conditions

• Recurrent Glioblastoma

Interventions

Type	Name	Description
PROCEDURE	Laser interstitial thermal therapy	Ablation of the tumor will be done by MRI-guided laser interstitial thermal therapy with the assistance of neuro-navigation.
DRUG	Temozolomide	Temozolomide will be administered continuously from the 1st to the 21st day after LITT surgery. The oral dose of temozolomide is 75 mg/m2. And then, it will be given at a routine dose from the second month after surgery.

Timeline

• Start date: 2022-12-01
• Primary completion: 2023-12-01
• Completion: 2024-12-30
• First posted: 2022-12-23
• Last updated: 2022-12-23

Locations

1 site across 1 country: China